Explore the vast range of titles available.

Clinical decision support systems (CDSSs) have been developed to give guidance for referring physicians to make appropriate decisions at the point of care. The MIDAS study, a multicenter cluster randomized trial at four German university hospitals, was designed to evaluate the effectiveness of a CDSS for imaging referral (ESR iGuide) in routine clinical care. Based on our experience within the MIDAS study, we aim to describe the hurdles and difficulties, as well as the various insights gained, in the process of implementing a CDSS in a clinical and research setting. To successfully implement a CDSS for imaging requests, it is essential to monitor and address technical issues, adapt local workflows, define the scope and content, and prioritize user experience and acceptance. Critical relevance statement By identifying and addressing the various technical, content-related, and workflow challenges, this article gives valuable insights to facilitate future implementations of the ESR iGuide and similar clinical decision support systems CDSSs for imaging orders. Trial registration number Approval from the Medical Ethics Review Committee was obtained under protocol numbers 20-069 (Augsburg), B 238/21 (Kiel), 20-318 (Lübeck) and 2020-15125 (Mainz). The trial is registered in the ClinicalTrials.gov register under registration number NCT05490290. Key Points This manuscript reviews the challenges of implementing a clinical decision support system (CDSS) (ESR iGuide). Clinical implementation of a CDSS for imaging requests requires monitoring and adjustments in technical issues, local workflow, scope and content, and attention to user experience and acceptance. Our experience may equip stakeholders with the knowledge to proactively address these challenges. Graphical Abstract

While frameworks to systematically assess bias in systematic reviews and meta-analyses (SRMAs) and frameworks on causal inference are well established, they are less frequently integrated beyond the data analysis stages. This paper proposes the use of Directed Acyclic Graphs (DAGs) in the design stage of SRMAs. We hypothesize that DAGs created and registered a priori can offer a useful approach to more effective and efficient evidence synthesis. DAGs provide a visual representation of the complex assumed relationships between variables within and beyond individual studies prior to data analysis, facilitating discussion among researchers, guiding data analysis, and may lead to more targeted inclusion criteria or set of data extraction items. We illustrate this argument through both experimental and observational case examples.

Purpose While meta-analyses of randomised studies suggest that neoadjuvant (NAC) or adjuvant (ACT) cisplatin-based chemotherapy improve overall survival in patients with muscle-invasive bladder cancer (MIBC), there are no trials comparing NAC against ACT in terms of quality-adjusted life years (QALYs) and costs. We aimed to evaluate the long-term QALYs, costs, and cost-effectiveness of different strategies for treating patients with MIBC. Methods An individual-level state transition microsimulation model was developed for patients with urothelial non-metastatic MIBC eligible for surgery and NAC at diagnosis. Four treatment strategies were evaluated: (i) no treatment, (ii) radical cystectomy (RC) without perioperative chemotherapy, (iii) NAC followed by RC, and (iv) RC followed by ACT. Primary endpoints were QALYs and costs. Sensitivity analysis on the probability of being fit for ACT after surgery was conducted to account for the uncertainty of this parameter. The model was face-validated independently by two urologists. Results Life-expectancy was 4.54 QALYs for ACT, 4.38 QALYs for NAC, 4.28 QALYs for RC without perioperative chemotherapy, and 2.84 QALYs for no treatment. Costs were lowest for ACT (US$45,805), compared to NAC (US$48,160), RC without perioperative chemotherapy (US$48,703), and no treatment (US$59,948). Sensitivity analysis suggested that NAC is associated with increased QALYs compared to ACT if the estimated probability of being fit for ACT is less than 38%. Limitations include the US-centric cost perspective. Conclusions In lack of comparative studies, simulated data suggests that ACT leads to increased QALYs and is cost-effective compared to NAC.